Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

Not Applicable

• Conditions: COVID-19
• Interventions: Drug: Favipiravir

• Registration Number: NCT04333589
• Lead Sponsor: Peking University First Hospital

Brief Summary

To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.

Detailed Description

In clinical institutions that enroll corona virus disease 2019 patients whose nucleic acids changed from negative to positive, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, favipiravir group and regular treatment group. 210 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( favipiravir group): 1(regular treatment group).

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-01
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-03
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-06-01
• Study Completion: 2020-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. COVID-19 has been diagnosed, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs has been negative for two consecutive times after treatment (sampling time interval of at least 24 hours);
2. The nucleic acid test of specimens such as sputum, throat swabs, blood, feces and other specimens was positive for COVID-19 during screening visits;
3. Voluntarily participate in research and sign informed consent.

Exclusion Criteria

1. Those allergic to fapilavir;
2. Pregnant or lactating women;
3. Unstable liver, kidney, and heart diseases;
4. History of mental disorders, substance abuse or dependence;
5. Researchers consider it inappropriate to participate in research;
6. Participating in other clinical research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Favipiravir group	Favipiravir	On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 14 days.

Primary Outcome Measures

Name	Time	Method
Viral nucleic acid test negative conversion rate	5 months	Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).

Secondary Outcome Measures

Name	Time	Method
Clinical cure rate	5 months	Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.

Trial Locations

Locations (8)

Ezhou Central Hospital; 🇨🇳 Wuhan, Hubei, China

Jinyintan Hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

Huoshenshan Hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

The Second People's Hospital of Fuyang; 🇨🇳 Fuyang, Anhui, China

Ezhou Hospital of Traditional Chinese Medicine; 🇨🇳 Ezhou, Hubei, China

Wuhan Pulmonary Hospital; 🇨🇳 Wuhan, Hubei, China

Wenzhou Medical University Affiliated First Hospital; 🇨🇳 Wenzhou, Zhejiang, China